FDA Device recall Z-1233-2026
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 by Encore Medical, citing 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1233-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-05 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Encore Medical |
| Distribution | AL, CA, IA, MA, MI, MO, MS, NJ, NY, OK, PA, PR, RI, TX |
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reason
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Identifiers
| code_info | UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2026%22
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